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A Study in Healthy People to Compare Two Different Sifrol® Tablets

NCT06457204 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 28

Last updated 2025-08-28

Study results available
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Summary

The main objective of this trial is to establish the bioequivalence of Sifrol® tablets manufactured at two different sites.

Conditions

  • Healthy

Interventions

DRUG

Pramipexole manufactured in Ingelheim

1 tablet Sifrol® (pramipexole) manufactured in Ingelheim containing 0.088 mg pramipexole taken orally after an overnight fast of at least 10 hours.

DRUG

Pramipexole manufactured in Ennigerloh

1 tablet Sifrol® (pramipexole) manufactured in Ennigerloh containing 0.088 mg pramipexole taken orally after an overnight fast of at least 10 hours.

Sponsors & Collaborators

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
CROSSOVER

Eligibility

Min Age
18 Years
Max Age
55 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2024-07-02
Primary Completion
2024-08-12
Completion
2024-08-12

Countries

  • Germany

Study Locations

More Related Trials

Entities

Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06457204 on ClinicalTrials.gov